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2DSCANNER L P

⚠️ High Risk

FEI: 3034879558 • Xanthi • GREECE

FEI

FEI Number

3034879558

📍

Location

Xanthi

🇬🇷

Country

GREECE
🏢

Address

O T 8 Synoikismos Ekten, , Xanthi, , Greece

High Risk

FDA Import Risk Assessment

51.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
2
Unique Violations
5/9/2025
Latest Refusal
5/9/2025
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
11.2×30%
Recency
86.5×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
5/9/2025
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
126FAILS STD
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is 2DSCANNER L P's FDA import refusal history?

2DSCANNER L P (FEI: 3034879558) has 1 FDA import refusal record(s) in our database, spanning from 5/9/2025 to 5/9/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. 2DSCANNER L P's FEI number is 3034879558.

What types of violations has 2DSCANNER L P received?

2DSCANNER L P has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about 2DSCANNER L P come from?

All FDA import refusal data for 2DSCANNER L P is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.